CASTLE BIOSCIENCES, INC. The report provides usage guidelines and a framework for clinicians to integrate GEP testing into their CM patient management. Additionally, the consensus report endorses Castle's DecisionDx-Melanoma GEP risk stratification test as offering more utility than other existing CM GEP assays or nomograms, supported by extensive, evidence-driven data in current literature.
'DecisionDx-Melanoma test results provide valuable information beyond current staging guidelines to help clinicians and patients make more informed, risk-aligned management decisions,' said
The report was compiled by a panel of six key opinion leaders in dermatology with specialized expertise in managing CM. The panel reviewed 32 studies published between 2019 through 2022 assessing the use of GEP testing in CM prognosis. Twenty-two of the studies reviewed assessed the utility of DecisionDx-Melanoma, Castle's 31-GEP risk stratification test designed to inform two clinical questions in the management of CM: a patient's individual risk of sentinel lymph node (SLN) positivity and a patient's personal risk of melanoma recurrence and/or metastasis. Based on a review of the studies, the panel developed six usage guidelines and five consensus supporting statements providing a framework for clinicians to integrate GEP testing into their CM patient management. Each of the recommendations was given a strength 'A,' 'B,' or 'C' according to Strength of Recommendation Taxonomy (SORT) criteria. The panel report, published in SKIN:
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient's individual risk of sentinel lymph node (SLN) positivity and a patient's personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma's clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test's results. Through
About
Castle's current portfolio consists of tests for skin cancers, uveal melanoma, Barrett's esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the 'safe harbor' created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of (i) DecisionDx-Melanoma to improve patient care and patient management, and overall disease outcomes, for patients with cutaneous melanoma, and (ii) GEP testing to improve prognostic assessment for patients with certain tumors and identify a high-risk subset for recurrence, distant metastasis, or death of traditionally assessed low-risk patients. The words 'can,' 'potential' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the recommendations and guidelines presented in this report, including with respect to the discussion of DecisionDx-Melanoma in this press release; actual application of our tests may not provide the aforementioned benefits to patients and the risks set forth under the heading 'Risk Factors' in our Annual Report on Form 10-K for the twelve months ended
Contact:
Email: czuckero@castlebiosciences.com
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